Aspen – South Africa Unveils Three-in-one HIV Drug

South African drug manufacturer, Aspen Pharmacare has unveiled a triple-combination tablet for the treatment of HIV where the virus is most prevalent in the country.

The drug known as Emdolten is a once-a-day tablet in the form of dolutegravir, an antiretroviral medication that counters the drug resistance that often develops with older HIV treatments, Aspen said.

The drug also contains lamivudine and tenofovir disoproxil fumarate alongside dolutegravir.

In May the South African Health Products Regulatory Authority and the European Medicines Agency issued a warning advising doctors not to prescribe dolutegravir to women seeking to become pregnant.

This followed preliminary data from a study in Botswana, which found four cases of neural tube defects in babies born to mothers who became pregnant while taking the drug.

The drug is found in the branded medicines Tivicay and Triumeq, which are sold by GlaxoSmithKline’s majority-owned ViiV Healthcare unit.

Aspen, which pioneered the development and manufacture of generic antiretrovirals (ARV) in South Africa, said that using dolutegravir was safe for men, women who are not of childbearing age and child-bearing women using contraceptives, adding that these groups represent more than 70 per cent of HIV patients.

“The fact that it (Emdolten) has been registered means that SAHPRA is comfortable that it is safe to take to the public,” Aspen strategic trade executive Stavros Nicolaou told Reuters, referring to South African Health Products Regulatory Authority.

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The company launched Aspen Stavudine – its first generic ARV drug in August 2003 – at a time when the country was grappling with a high rate of HIV infection.

South Africa has 19 per cent of the global number of people living with HIV, 15 per cent of new infections and 11 per cent of AIDS-related deaths, the United Nations AIDS agency says on its website.

There is no vaccine to prevent HIV/AIDS. Current treatments only helping patients to manage the disease, but the fast-mutating virus has proved a challenge to the medical community because it often develops resistance to existing medicines.

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